205777orig1s000 - food and drug administration · the ondqa biopharmaceutics team has reviewed nda...

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

205777Orig1s000

CHEMISTRY REVIEW(S)

---------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.---------------------------------------------------------------------------------------------------------/s/----------------------------------------------------

JULIA C PINTO06/27/2014

ERIC P DUFFY07/07/2014

Reference ID: 3533068


EUGENIA M NASHED06/14/2014



ONDQA Initial Quality Assessment (IQA) and Filing Review For Pre-Marking Applications

Office of New Drug Quality Assessment (ONDQA) Internal Quality Procedure 5106 Record AEffective Date: 09/01/2013 Page 2 of 24

5. NAME OF APPLICANT (as indicated on Form 356h):

Purdue Pharma L.P.One Stamford Forum201 Tresser BlvdStamford, CT 06901-3431

6. SUBMISSION PROPERTIES:

Review Priority: Priority Review

Submission Classification (Chemical Classification Code):

Application Type: 505(b)(2)

Breakthrough Therapy No

Responsible Organization(Clinical Division):

DAAAP

7. CONSULTS:

CONSULT YES NO COMMENTS: (list date of request if already sent)Biometrics XClinical Pharmacology XEstablishment Evaluation Request (EER)

X EES entered September 26, 2013 by Luz Riviera

Pharmacology/Toxicology XMethods Validation XEnvironmental Assessment XCDRH X

Other XMicrobiology Consult Sent: September 30, 2013Steven Donald is the assigned Microbiologist Reviewer




Parameter Yes No Comment

7.

Are drug substance manufacturing sites identified on FDA Form 356h or associated continuation sheet? For each site, does the application list: Name of facility, Full address of facility including

street, city, state, country FEI number for facility (if previously

registered with FDA) Full name and title, telephone, fax

number and email for on-site contact person.

Is the manufacturing responsibility and function identified for each facility?, and

DMF number (if applicable)

X

8.

Are drug product manufacturing sites identified on FDA Form 356h or associated continuation sheet. For each site, does the application list: Name of facility, Full address of facility including

street, city, state, country FEI number for facility (if previously

registered with FDA) Full name and title, telephone, fax

number and email for on-site contact person.

Is the manufacturing responsibility and function identified for each facility?, and

DMF number (if applicable)

X




INITIAL BIOPHARMACEUTICS ASSESSMENT

This 505(b)(2) NDA references the listed drug Narcan, naloxone hydrochloride (NDA 016636) and cross-references original OxyContin®, oxycodone hydrochloride (NDA 020553) and reformulated OxyContin®, oxycodone hydrochloride (NDA 022272). The Applicant has conducted the relative bioavailability study ONU1009, which established a pharmacokinetic (PK) bridge of each component of Targiniq (oxycodone and naloxone) to approved products, OxyContin (oxycodone) and Narcan (naloxone, via an ANDA generic designated as the Reference Listed Drug for Narcan).

The Biopharmaceutics information in this submission includes a drug product development section with the proposed dissolution method, the proposed dissolution acceptance criterion, information/data on alcohol dose dumping, data supporting the acceptability of the Level manufacturing site change for each strength, data supporting production batch scale-up for each strength, and data supporting the in vitro in vivo relationship (IVIVR) for the oxycodone component of the proposed drug product.

The proposed dissolution method is:

USPApparatus

Rotation Speed

MediaVolume

Temp Medium

2 50 rpm 900 mL 37 °C SGF (pH 1.2) w/o enzyme

The proposed acceptance criteria for both oxycodone HCl and naloxone HCl are:

10 mg/5 mg Strength

Acceptance Criteria

15 min: % 2 hr: % 10 hr: NLT %

20 mg/10 mg Strength

Acceptance Criteria

15 min: % 2 hr: % 10 hr: NLT %

40 mg/20 mg Strength

Acceptance Criteria

15 min: % 2 hr: % 10 hr: NLT %

The Biopharmaceutics review will focus on the evaluation and acceptability of: 1) the proposed dissolution methodology,2) the proposed dissolution acceptance criteria,3) information/data on in vitro alcohol dose dumping,


(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)



4) information/data on abuse deterrent studies (in vitro) 5) the BE and dissolution data supporting the Level manufacturing site change, 6) the BE and dissolution supporting production batch scale-up, and7) data supporting the IVIVR model for the oxycodone component of the proposed drug product.

RECOMMENDATION:

The ONDQA Biopharmaceutics team has reviewed NDA 205-777 for filing purposes. We found this NDA fileable from a Biopharmaceutics perspective. The Applicant has submitted a reviewable submission.


(b) (4)



This document will be sequentially signed in DARRTS by all of the following who authored or reviewed this assessment:

See appended electronic signature page}

NAME : Julia Pinto, Ph.D. CMC-Lead Division IIIOffice of New Drug Quality Assessment

{See appended electronic signature page}

NAME: Kareen RivieriBiopharmaceutics ReviewerOffice of New Drug Quality Assessment


NAME: Tapash Ghosh, Ph.D.Biopharmaceutics Team Leader or DesigneeOffice of New Drug Quality Assessment


NAME: Prasad Peri, Ph.D.Branch Chief or DesigneeDivision IIIOffice of New Drug Quality Assessment




KAREEN RIVIERE11/18/2013

TAPASH K GHOSH11/19/2013

PRASAD PERI11/20/2013I concur


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